Background The Celecoxib Long-term Arthritis Safety Study (CLASS), a prospective outcomes study conducted in North America, demonstrated a significant reduction in UGI ulcer complications and improved tolerability.
Objectives To extend our understanding of the UGI safety advantages of celecoxib over conventional nonsteroidal anti-inflammatory drugs (NSAIDs), in day-to-day practice, a naturalistic study was conducted worldwide.
Methods SUCCESS I, a large, 12-week, multinational, double-blind, randomised trial in 13,274 osteoarthritis patients, was conducted in 39 countries. There were 6547 patients from Europe/Africa, 2756 from North America, 2889 from Latin America, and 1082 from Asia/Pacific. Celecoxib 200 mg/d (n = 4421) and 400 mg/d (n = 4429) was compared with naproxen 1000 mg/d (n = 914) and diclofenac 100 mg/d (n = 3510) with regard to GI tolerability.
Results The frequency of all reported GI adverse events (AEs), the three most frequently reported UGI AEs, and withdrawals due to GI AEs are shown in the Table 1.
Conclusion UGI symptoms, more commonly associated with NSAID use, were consistently and significantly lower with celecoxib. The percent reduction ranged from 18.6% to 29.4%. These data confirm the superior GI tolerability of celecoxib vs conventional NSAIDs and establish that this difference is clinically meaningful in terms of discontinuation of therapy for such symptoms. Sponsored by Pharmacia Corporation and Pfizer, Inc.
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